Project Specialist (clinical experience)

Syneos Health, Inc.; Indiana; On-site; USD 60,000 - 90,000; Full time

Job summary

Syneos Health is seeking a Project Specialist (clinical experience) to support clinical study timelines in Indiana. You will coordinate timelines, budgets, and vendor management, while ensuring SOP and GCP compliance across trials.

The role requires strong organizational and communication skills, with experience in clinical project management and proficiency in Microsoft Office. You will collaborate with cross-functional teams to deliver trials on schedule and within budget.

Qualifications

• High school diploma or equivalent.
• Associate's degree or higher in a related field preferred.
• Minimum of 3 years of experience in clinical project management or a related field.
• Strong understanding of clinical trial processes and regulations.
• Experience with SOP, GCP, and country-specific regulations.

Responsibilities

• Should have min 1 yr of relevant experience.
• Strong multitasking and organizational skills.
• Excellent communication and interpersonal abilities.
• Ability to work independently and collaboratively.
• Advanced Excel skills for financial review and reporting.
• Planning, directing, creating, and communicating clinical study timelines, ensuring milestones are met and the project stays on track.
• Gathering input from cross-functional teams to create comprehensive plans for timely deliverables.
• Ensuring consistency of clinical study processes across trials by standardizing procedures and implementing best practices.
• Overseeing and resolving operational aspects of clinical trials, including addressing any issues that arise and ensuring SOP and GCP compliance.
• Selecting sites and vendors for clinical trials, negotiating contracts, and managing relationships.
• Preparing clinical trial budgets, monitoring expenditures, and ensuring that the study remains within budget.
• Monitoring progress of clinical trials, tracking KPIs, and following up with team members and line managers to address deviations from the plan.
• Implementing and preparing the clinical development strategy as outlined by the clinical teams.
• Developing trial recruitment strategies, including identifying target populations and monitoring enrollment progress.

Skills

Organizational skills

Time management

Communication

Interpersonal skills

Teamwork

MS Office Suite

Education

High school diploma or equivalent

Associate's degree or higher in related field

Job description

Project Specialist (clinical experience)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• Should have min 1 yr of relevant experience.
• Strong multitasking and organisational skills
• Excellent communication and interpersonal abilities
• Ability to work independently and collaboratively
• Advanced Excel skills for financial review and reporting
• Planning, directing, creating, and communicating clinical study timelines, ensuring that all milestones are met and that the project stays on track
• Gathering input from cross-functional teams, including clinical, regulatory, and data management, to create comprehensive plans for timely deliverables
• Ensuring consistency of clinical study processes across trials by standardizing procedures and implementing best practices
• Overseeing and resolving operational aspects of clinical trials, including addressing any issues that arise during the study and ensuring that all activities are conducted in compliance with SOP, GCP, and specific country regulations
• Selecting sites and vendors for clinical trials, negotiating contracts, and managing relationships to ensure high-quality and timely delivery of services
• Preparing clinical trial budgets, monitoring expenditures, and ensuring that the study remains within budget
• Monitoring progress of clinical trials, tracking key performance indicators, and following up with team members and line managers to address any deviations from the plan
• Implementing and preparing the clinical development strategy as outlined by the clinical teams, ensuring alignment with overall project goals and objectives
• Developing trial recruitment strategies, including identifying target populations, creating recruitment materials, and monitoring enrollment progress

Qualifications

• High school diploma or equivalent required
• Associate's degree or higher in a related field preferred
• Minimum of 3 years of experience in clinical project management or a related field
• Strong understanding of clinical trial processes and regulations
• Experience with SOP, GCP, and country-specific regulations

Certifications

• Certification in Clinical Project Management or related field preferred
• Good Clinical Practice (GCP) certification preferred

Necessary Skills

• Excellent organizational and time management skills
• Strong communication and interpersonal skills
• Ability to work effectively in a team environment
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Attention to detail and problem-solving skills
• Ability to adapt to changing priorities and work under pressure

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Project Management at the S11 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. Individuals ensure consistency of clinical study processes across clinical trials, overseeing and resolving operational aspects in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. This includes site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. The roles involve monitoring progress and following up with team members and line managers when issues develop. Additionally, individuals implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. Impact and Contribution Individuals in these roles significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By creating and communicating clear timelines and plans, they help the team stay on track and meet deliverables on schedule. Their oversight of operational aspects and adherence to SOP, GCP, and country regulations ensures the integrity and quality of the clinical trials. Their contributions to site and vendor selection, budget preparation, and strategy implementation are crucial for the smooth execution of clinical studies. Their ability to monitor progress and address issues promptly helps maintain the momentum of the trials and supports the overall clinical development strategy.

Core Focus

• Planning, directing, creating, and communicating clinical study timelines
• Gathering input from cross-functional teams to create plans for timely deliverables
• Ensuring consistency of clinical study processes across trials
• Overseeing and resolving operational aspects of clinical trials
• Adhering to SOP, GCP, and specific country regulations
• Selecting sites and vendors for clinical trials
• Preparing clinical trial budgets
• Monitoring progress and following up with team members and line managers
• Implementing and preparing the clinical development strategy
• Developing trial recruitment strategies